Line 3 Work Instruction (6mm Slitting, Vial Filling, Capping)¶
Version: v1.0
1. Purpose¶
Define standardized conversion of good rows into 6mm final test strips, vial packaging and capping.
2. Scope¶
Applies to semi-automatic 6mm slitter stations (4 machines) and vial capping machine in ISO-7 environment.
3. Equipment¶
- 6mm Cell Slitter Machines (4 stations, operator controlled; manual mode for partial-defect rows)
- Vial loading trays (2 vials per cycle)
- Automatic Vial Capping Machine (press-type, top press not screw)
- Vial transporter conveyor
- Scale (for count verification after capping)
- Interlock Pass-Through Chamber (transfer to Packing Room)
4. Inputs¶
- Good rows (segregated, labeled)
- Partial-defect rows (for manual mode processing)
- Clean vials (pre-qualified)
- Vial caps & desiccant (if required)
5. Procedure¶
| Step | Description | Detail | Record |
|---|---|---|---|
| 1 | Equipment check | Verify 6mm slitter blades sharpness & guard | Pre-check list |
| 2 | Row loading | Load GOOD rows into slitter container | Batch record |
| 3 | Vial preparation | Place 2 vials in tray (choose 25/50 pcs mode) | Setting log |
| 4 | Start slitting | Start semi-auto cycle; monitor feed | Slitter counter |
| 5 | Auto vial filling | 6mm strips slide into vials | Counter log |
| 6 | Remove vials | Remove filled vials; place on transporter | Batch record |
| 7 | Capping machine | Automatic press-capping (top press) | Capper log |
| 8 | Weight sampling | Use scale to verify count (weight check) | QC sample sheet |
| 9 | Interim storage | Place capped vials in ready goods container | Inventory sheet |
| 10 | Transfer | Transfer to Packing Room via Interlock Pass-Through Chamber | Transfer log |
5a. Partial-Defect Row Processing¶
| Step | Description | Detail | Record |
|---|---|---|---|
| 1 | Mode switch | Switch slitter to MANUAL mode | Mode log |
| 2 | Row loading | Load partial-defect rows into slitter | Batch record |
| 3 | Manual slitting | Operator manually removes bad strips during slitting | Reject count |
| 4 | Vial filling | Good strips slide into vials | Counter log |
| 5 | Continue | Continue with capping and weighing as normal process | Batch record |
6. Acceptance Criteria¶
| Parameter | Requirement |
|---|---|
| Strip Width | 6.0 mm ±0.1 mm |
| Count per Vial | 25±0 or 50±0 (verified by weight) |
| Physical Damage | 0 cracks / bends sampled 50 pcs |
| Cap Seal | Secure press-fit, no loose caps |
| Strip Orientation | Electrode side uniform (visual) |
7. Loss Tracking¶
Record any broken / rejected strips; investigate >0.5% loss per lot.
8. Records¶
- Line 3 Batch Record
- Slitter count log
- Scale verification sheet
- Partial-defect row processing log
- Transfer log (Interlock Chamber)
9. Reaction Plan¶
If miscounts occur: use scale to verify count; recount manually if needed. High breakage: inspect blade wear & row tension alignment.
10. Safety¶
Keep hands clear of slitter feed path; lockout/tagout for blade change. Avoid inhalation of any particulate (use local extraction if needed).
Revision History: v1.0 Initial release.